Biologics management

Reflexive approaches to optimize treatment

Many patients may have flare-ups of their disease, or they may stop responding to treatment. In these situations, the clinician may choose to increase the dose administered or recommend more frequent injections. One cause of decreased response to treatment is the appearance of anti-drug antibodies, or “immunogenicity.”

To monitor for immunogenicity, we have implemented a reflexive testing approach that aligns with American Gastroenterology Association (AGA) guidelines. This approach first measures the biologic concentration within a patient’s specimen. Then, if necessary, an additional test is performed to assess the presence of antibodies to a specific drug that the patient has been receiving. The information from these tests helps health care providers determine if their patients are experiencing a loss of response to a specific therapy. If so, clinicians can adjust treatment plans.

Benefits of our reflexive approach

Clinically significant antibodies to these drugs are found in patients with very low trough concentrations in their serum. Therefore, a reflexive approach, which performs testing only when it is clinically relevant, benefits patients and reduces costs for the ordering institution.

When do these tests reflex?

When concentration results are below a specified level, testing for antibodies to the specific drug will be performed at an additional charge.

Adalimumab≤ 8.0 mcg/mL
Infliximab≤ 5.0 mcg/mL
Vedolizumab≤ 15.0 mcg/mL

Which test should I order?

Panel testing for newer therapies without established therapeutic thresholds

For newer therapies that do not yet have well-established therapeutic thresholds and optimal concentrations associated with good outcomes, we offer testing that performs both quantitation and antibody testing on all specimens.

As more data is generated for these therapies, and as guidelines are updated, creation of reflex testing panels will be pursued.

Which test should I order?

Edward Loftus, M.D., talks biologic therapies

Edward Loftus Jr., M.D., a gastroenterologist at Mayo Clinic, provides an overview of our reflexive approach to optimizing treatment for inflammatory bowel disease.

Clinical action enabled by this testing

Learn more about how to order this evaluation at your institution.